Expanding seal anchor for single incision surgery

ABSTRACT

The present disclosure relates to a surgical anchoring apparatus for use during a minimally invasive surgical procedure. The surgical anchoring apparatus includes a body member and a dilator element at least partially positionable therein. The body member includes a grip segment adapted for manual engagement by a user and an expandable section having a plurality of expandable segments and a plurality of cam surfaces. The grip segment resiliently transitions between a first or normal state and a second state in which the grip segment is at least partially inverted. The expandable section&#39;s cam surfaces are configured to engage a distal end of the dilator element upon its insertion such that the expandable section may transition from an initial condition to an expanded condition in which the body member is secured or anchored within an incision in tissue.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/997,844 filed on Oct. 5, 2007, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to a device, and a method of use thereof,for facilitating access to a patient's internal cavities during asurgical procedure. More particularly, the present disclosure relates toa surgical anchoring apparatus adapted for insertion into an incision intissue, and for the sealed reception of one or more surgical objects, soas to form a substantially fluid-tight seal with both the tissue and thesurgical object, or objects.

2. Background of the Related Art

Today, many surgical procedures are performed through small incisions inthe skin, as compared to the larger incisions typically required intraditional procedures, in an effort to reduce trauma to the patient andrecovery time. Generally, such procedures are referred to as“endoscopic”, unless performed on the patient's abdomen, in which casethe procedure is referred to as “laparoscopic”. Throughout the presentdisclosure, the term “minimally invasive” should be understood toencompass both endoscopic and laparoscopic procedures. During a typicalminimally invasive procedure, surgical objects, such as surgical accessdevices, e.g. trocar and cannula assemblies, or endoscopes, are insertedinto the patient's body through the incision in tissue.

In generally, prior to the introduction of the surgical object into thepatient's body, insufflation gasses are used to enlarge the areasurrounding the target surgical site to create a larger, more accessiblework area. Accordingly, the maintenance of a substantially fluid-tightseal at the incision and about the surgical object, or objects, isdesirable so as to prevent the escape of the insufflation gases and thedeflation or collapse of the enlarged surgical work area.

To this end, various apparatus, including valves, seals and the like,are used during the course of minimally invasive procedures and arewidely known in the art. However, a continuing need exists for aself-anchoring apparatus that can be inserted directly into the incisionin tissue and that can accommodate a variety of surgical objects whilemaintaining the integrity of an insufflated workspace.

SUMMARY

In one aspect of the present disclosure, a surgical anchoring apparatusincludes a body member defining a longitudinal body passage extendingalong a longitudinal axis thereof, a dilator element at least partiallypositionable within the longitudinal passage of the body member and aseal mounted with respect to the dilator element.

The body member includes an expandable section adapted to transitionbetween a first initial condition and a second expanded condition. Theexpandable section of the body member includes a plurality of expandablesegments separated by slots, which may be substantially longitudinal,and a plurality of internal cam surfaces that are obliquely arrangedwith respect to the longitudinal axis defined by the body member. In oneembodiment, each of the expandable segments includes an internal camsurface. The expandable section further includes an outer helical threadadapted to facilitate the advancement of the body member within tissuewhen the body member is in the first initial condition.

The body member also includes a grip segment adapted for manualengagement by a user. The grip segment depends radially outwardlyrelative to the longitudinal axis of the body member. The grip segmentis adapted to transition between a normal state and an at leastpartially inverted state. The grip segment may comprise an elastomericmaterial, and have a peripheral flange that is adapted to contact tissuewhen the grip segment is in the normal state. The peripheral flange maybe adapted to establish a vacuum seal with the tissue upon transition ofthe grip segment from the at least partially inverted state to thenormal state.

The dilator element is dimensioned to cause the expandable section totransition to the second expanded condition when inserted into theexpandable section to thereby facilitate securement of the body memberrelative to tissue. The dilator element defines a longitudinal dilatorpassage for the reception and passage of a surgical object. The dilatorelement is dimensioned to contact the cam surfaces during insertion ofthe dilator element within the longitudinal passage of the body memberto move the expandable segments at least radially outwardly relative tothe longitudinal axis and cause the transition of the expandable sectionto the second expanded condition.

The seal is adapted to establish a substantial sealing relation with thesurgical object received within the dilator element. In alternateembodiments, the seal may include a gel material or a self healing foammaterial.

These and other features of the valve disclosed herein will become morereadily apparent to those skilled in the art from the following detaileddescription of various embodiments of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith references to the drawings, wherein:

FIG. 1 is a side perspective view of a surgical anchoring apparatus inaccordance with the principles of the present disclosure illustrating abody member and a dilator element.

FIG. 2 is a side cross-sectional view of the surgical anchoringapparatus of FIG. 1 with the dilator element removed from the bodymember.

FIG. 3 is a side cross-sectional view of the surgical anchoringapparatus of FIG. 2 with the dilator element inserted in the bodymember.

FIG. 4 is a top perspective view of the surgical anchoring apparatus ofFIG. 1 illustrating details of the seal.

FIG. 5 is a side plan view of the body member of the surgical anchoringapparatus illustrating the grip segment in a first inverted state.

FIG. 6 is a side plan view of the body member of the surgical anchoringapparatus illustrating the grip segment in a second normal state.

FIG. 7 is a side plan view of the surgical anchoring apparatusillustrating the dilator element inserted through the body member, andan expandable section of the body member in a second, expandedcondition.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In the drawings and in the description which follows, in which likereference numerals identify similar or identical elements, the term“proximal” will refer to the end of the apparatus which is closest tothe clinician during the use thereof, while the term “distal” will referto the end which is furthest from the clinician, as is traditional andknown in the art.

With reference now to FIGS. 1-2, a surgical anchoring apparatus 1000 isdisclosed for use in a surgical procedure, e.g. a minimally invasiveprocedure. Anchoring apparatus 1000 includes a body member 10 and adilator element 300 at least partially positionable therein. Body member10 defines a longitudinal axis “A” and a longitudinally extendingpassage 12 and includes a grip segment 100 and an expandable section200.

Grip segment 100 depends radially outward relative to the longitudinalaxis “A” of body member 10 and includes an outer surface 102 having anaperture 104 formed therein that is dimensioned to receive dilatorelement 300. Outer surface 102 extends outwardly from aperture 104 to aperipheral flange 106. Peripheral flange 106 is adapted to contact andestablish a substantially vacuum quality seal with tissue “T” (see FIGS.6-7), as discussed below.

Grip segment 100 is adapted for manual engagement by a user and toresiliently transition between a first or normal state (FIGS. 1-4) and asecond state (FIG. 5). In the first state, outer surface 102 of gripsegment 100 exhibits a substantially distal curvature in whichperipheral flange 106 is directed distally. In the second state, gripsegment 100 is at least partially inverted such that at least a portionof outer surface 102 exhibits a substantially proximal curvature suchthat peripheral flange 106 is directed proximally. In this state, gripsegment 100 is more aptly configured for manual engagement by a user tofacilitate the insertion of expandable section 200 into an incision 14(FIG. 5), as discussed in further detail below. It should be noted thatengagement by a user is also possible when grip segment 100 is in thefirst state. Grip segment 100 may be formed of any suitablebiocompatible material that is sufficiently flexible to permit gripsegment 100 to resiliently transition between the first and secondstates, including but not being limited to elastomeric materials.

Expandable section 200 extends distally from grip segment 100 and is insubstantial alignment with aperture 104 of grip segment 100 such thatdilator element 300 may pass through aperture 104 and into expandablesection 200 upon insertion. At its distal end 202, expandable section200 defines an opening 204 that is dimensioned to allow a distal end 304of dilator element 300 to pass therethrough. Expandable section 200 isadapted to transition from a first, or initial condition (FIG. 6) to asecond, or expanded condition (FIG. 7).

Expandable section 200 defines a length “L” that is sufficient toprovide percutaneous access to a patient's underlying cavities, organsand the like (not shown). Expandable section 200 includes a plurality ofexpandable segments 206, a plurality of internal cam surfaces 208 and anouter helical thread 210.

Expandable segments 206 are defined by two or more slots 212. In oneembodiment, slots 212 extend in a substantially longitudinal manner.However, alternate configurations for slots 212 are not beyond the scopeof the present disclosure. Upon the transition of expandable section 200from the initial condition to the expanded condition, expandablesegments 206 are splayed radially outward, as discussed in furtherdetail below.

Internal cam surfaces 208 are obliquely arranged with respect to thelongitudinal axis “A” defined by body member 10. Internal cam surfaces208 are configured to engage a tapered outer surface 308 of dilatorelement 300 upon its insertion into longitudinal passage 12 of bodymember 10 to facilitate the transition of expandable section 200 fromthe initial condition to the expanded condition, as discussed in furtherdetail below. In one embodiment, each expandable segment 206 includes aninternal cam surface 208. Outer helical thread 210 is disposed on theouter surface of expandable section 200. Helical thread engages tissue“T” upon the insertion of expandable section 200 into incision 14 so asto facilitate the distal advancement of body member 10. In addition,helical thread 210 may assist in the anchoring of body member 10 withintissue “T”.

Expandable section 200 may be formed of any suitable biocompatiblematerial that is sufficiently resilient to permit resilient expandablesection 200 to resiliently transition between the initial and expandedconditions thereof.

In its first, or normal condition, expandable section 200 is configuredfor insertion into incision 14 and defines a first diameter “D₁”. Uponthe insertion of dilator element 300, a distal end 304 thereof engagescam surfaces 208. As dilator element 300 is advanced distally throughlongitudinal passage 12, its distal end 304 forces cam surfaces 208, andexpandable segments 206, outwardly to thereby transition expandablesection 200 into its expanded condition. In its expanded condition,expandable section 200 defines a second, larger diameter “D₂”.

Dilator element 300 has a proximal end 302 that includes a seal 400 anda gripping portion 306 that is configured for grasping by a user duringthe distal advancement of dilator element 300 through body member 10.

Dilator element 300 defines a longitudinal passage 308 that extendstherethrough from its proximal end 302 to its distal end 304 where anopening 310 is defined. Longitudinal passage 308 defines a diameter “D”and is configured to removably receive one or more surgical objects “I”(FIG. 7), e.g. a trocar, endoscope or surgical stapler. The diameter “D”of longitudinal passage 308 may range between about 3 mm to about 15 mm,or may be substantially within the range of about 5 mm to about 12 mm.However, the use of surgical objects having substantially larger andsmaller diameters is contemplated herein, as is a dilator element 300defining a longitudinal passage 308 with a substantially larger orsmaller diameter “D” so as to accommodate such surgical objects. In oneembodiment, the longitudinal dilator passage 308 is divided into aplurality of individual lumens (not shown) separated by at least oneseptum. Each of the individual lumens may be of either substantiallysimilar or substantially different dimensions and are each configured toreceive a surgical object.

Dilator element 300 may be formed of any biocompatible material that issufficiently rigid to urge the expandable segments 206 of expandablesection 200 outwardly upon its insertion into longitudinal body passage12 and thereby transition expandable portion 200 from its normalcondition to its expanded condition.

Referring now to FIGS. 4 and 7, seal 400 is associated with proximal end302 of dilator element 300 and may be mounted thereto. Seal 400 definesan aperture 402 and is adapted to transition from a closed condition(FIG. 4) to an open condition (FIG. 7) upon the insertion of surgicalobject “I”. In the closed condition, aperture 402 defines a firstdimension “D_(S1)” of about 0 mm so as to substantially prevent theescape of any insufflation gas (not shown) therethrough in the absenceof surgical object “I”. Upon the insertion of surgical object “I”,aperture 402 is forced open, thereby transitioning seal 400 into theopen condition. In this condition, aperture 402 defines a seconddimension “D_(S2)” that substantially approximates the diameter “D_(I)”of surgical object “I” such that seal 400 forms a substantiallyfluid-tight seal with surgical object “I”, thereby substantiallypreventing the escape of any insufflation gas through seal 400. Surgicalobject “I” will generally define a diameter substantially within therange of about 5 mm to about 12 mm. Accordingly, in the secondcondition, aperture 402 will generally define a second dimension“D_(S2)” that is also substantially within the range of about 5 mm toabout 12 mm. However, the use of surgical objects having substantiallylarger and smaller diameters is contemplated herein, as is a seal 400with an aperture 402 that is capable of accommodating such surgicalobjects.

Seal 400 may be formed of any suitable biocompatible material that is atleast semi-resilient in nature such that seal 400 may transition betweenthe closed and open conditions thereof. Seal 400 may be any seal orvalve suitable for the intended purpose of removably receiving asurgical object in sealed relation therewith, including but not beinglimited to a slit-valve or a zero closure valve.

The use and function of anchoring apparatus 1000 during the course of aminimally invasive procedure will now be discussed. Initially, theperitoneal cavity (not shown) is insufflated with a suitablebiocompatible gas such as, e.g., CO₂ gas, such that the cavity wall israised and lifted away from the internal organs and tissue housedtherein, providing greater access thereto. The insufflation may beperformed with an insufflation needle or similar device, as isconventional in the art. Either prior or subsequent to insufflation, anincision 14 is created in tissue “T”, the dimensions of which may bevaried dependent upon the nature of the surgical procedure.

Prior to the insertion of anchoring apparatus 1000 within incision 14,dilator element 300 is removed from body 10. Thereafter, the clinicianmay transition grip segment 100 from the first state (FIGS. 1-4) to thesecond state (FIG. 5) to facilitate the manual engagement thereof andthe insertion of body member 10. To realize this transition, the user atleast partially inverts grip segment 100 such that the outer surface 102exhibits a proximal curvature. Once in the second state, the clinicianmay more easily grasp grip segment 100, e.g. about peripheral flange106.

The distal end 206 of expandable section 200 is then inserted into andadvanced distally through incision 14. Optionally, the clinician mayrotate body 10, e.g. clockwise in the direction of arrows “B”, duringinsertion such that helical thread 210 facilitates the distaladvancement of expandable section 200. After expandable section 200 hasbeen completely inserted within the patient's tissue “T”, grip segment100 is returned to its first state such that peripheral flange 106 is inengagement with tissue “T”. Grip segment 100 may form a substantiallyvacuum seal with tissue “T”. (See FIGS. 6-7).

Subsequently, dilator element 300 is inserted through aperture 104 ingrip segment 100, into longitudinal body passage 202, distallytherethrough and into expandable section 200. During the distaladvancement of dilator element 300, its distal end 304 engages camsurfaces 208, thereby forcing the plurality of expandable segments 206outwardly and transitioning expandable section 200 from the normalcondition (FIG. 6) to the expanded condition (FIG. 7). As previouslydiscussed, in the normal condition, expandable section 200 defines afirst diameter “D₁” and in the expanded condition, expandable section200 defines a second, larger diameter “D₂”.

During the transition from the first condition to the second condition,expandable section 200 expands outwardly and exerts a force “F” upontissue “T” which dilates incision 14. Force “F” creates a correspondingbiasing force “F_(B)” within tissue “T” that attempts to close incision14. Forces “F” and “F_(B)” collaborate to secure and anchor expandablesection 200 within tissue “T” in a substantially fluid tight manner suchthat the escape of insufflation gas about anchoring apparatus 1000 issubstantially prevented. In addition, while inserted within tissue “T”,helical thread 210 is disposed distally, and perhaps proximally, oftissue “T”, thereby further securing the disposition and anchoring ofexpandable section 200 within tissue “T”.

Finally, surgical object “I” is inserted and advanced distally throughthe seal 400 associated with the proximal end 302 of dilator element300, through longitudinal dilator passage 308 and ultimately throughopening 310 at the distal end 304 of dilator element 300. Thereafter,the remainder of the surgical procedure may be carried out usingsurgical object “I”.

Upon completion of the surgical procedure, surgical object “I” iswithdrawn from dilator element 300 through seal 400. Dilator element 300is then withdrawn from expandable section 200 through longitudinal bodypassage 202 and through aperture 104 in grip segment 100. During thewithdrawal of dilator element 300, force “F” dissipates, as does thecorresponding biasing force “F_(B)” in tissue “T”, thereby facilitatingthe withdrawal of expandable section 200. The user may then transitiongrip segment 100 from the first state to the second state and withdrawbody member 10 from incision 14, optionally rotating body member 10during withdrawal. Incision 14 may then be closed.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, theabove description, disclosure, and figures should not be construed aslimiting, but merely as exemplifications of particular embodiments. Itis to be understood, therefore, that the disclosure is not limited tothose precise embodiments, and that various other changes andmodifications may be effected therein by one skilled in the art withoutdeparting from the scope or spirit of the disclosure.

What is claimed is:
 1. A surgical anchoring apparatus configured anddimensioned for positioning within tissue, which comprises: a bodymember having proximal and distal ends, and defining a longitudinal bodypassage extending along a longitudinal axis of the body member, the bodymember including an expandable section adapted to transition between afirst initial condition and a second expanded condition, wherein thebody member includes a grip segment adapted for manual engagement by auser depending radially outwardly relative to the longitudinal axis ofthe body member, the grip segment being adapted to transition between anormal state and an at least partially inverted state, the grip segmentbeing secured to the proximal end of the body member such that the gripsegment extends proximally from the body member; a dilator element atleast partially positionable within the longitudinal passage of the bodymember, and being dimensioned to cause the expandable section totransition to the second expanded condition during insertion of thedilator element in the longitudinal passage, to thereby facilitatesecurement of the body member relative to tissue, the dilator elementdefining a longitudinal dilator passage for reception and passage of asurgical object; and a seal secured to the dilator element, the sealadapted to establish a substantial sealing relation with the surgicalobject received within the dilator element.
 2. The surgical anchoringapparatus according to claim 1 wherein the expandable section of thebody member includes a plurality of expandable segments.
 3. The surgicalanchoring apparatus according to claim 2 wherein the expandable sectionincludes a plurality of internal cam surfaces extending inwardly from aninternal surface of the expandable section and obliquely arranged withrespect to the longitudinal axis, the dilator element being dimensionedto contact the cam surfaces during insertion of the dilator elementwithin the longitudinal passage of the body member to move theexpandable segments at least radially outwardly relative to thelongitudinal axis and cause the transition of the expandable section tothe second expanded condition.
 4. The surgical anchoring apparatusaccording to claim 3 wherein each expandable segment includes aninternal cam surface.
 5. The surgical anchoring apparatus according toclaim 4 wherein adjacent expandable segments of the expandable sectionof the body member are separated by slots.
 6. The surgical anchoringapparatus according to claim 5 wherein adjacent expandable segments areseparated by substantially longitudinal slots.
 7. The surgical anchoringapparatus according to claim 3 wherein the expandable section includesan outer helical thread adapted to facilitate advancement of the bodymember within the tissue when the body member is in the first initialcondition.
 8. The surgical anchoring apparatus according to claim 1wherein the grip segment comprises an elastomeric material.
 9. Thesurgical anchoring apparatus according to claim 8 wherein the gripsegment includes a peripheral flange oriented towards the tissue in thenormal state such that the peripheral flange is positioned to contactthe tissue, and oriented away from the tissue in the at least partiallyinverted state.
 10. The surgical anchoring apparatus according to claim9 wherein the peripheral flange is adapted to establish a vacuum sealwith the tissue during transition of the grip segment from the at leastpartially inverted state to the normal state.
 11. The surgical anchoringapparatus according to claim 1 wherein the seal includes a gel material.12. The surgical anchoring apparatus according to claim 1 wherein theseal includes a self healing foam material.
 13. The surgical anchoringapparatus according to claim 1 wherein the expandable section includes afirst portion defining a transverse cross-sectional dimension thatdecreases in a proximal direction, whereby the first portion of theexpandable section is tapered in configuration, and a second portionpositioned adjacent a distal end of the first portion, the secondportion having a substantially constant transverse cross-sectionaldimension.
 14. A surgical anchoring apparatus configured and dimensionedfor positioning within tissue, which comprises: a grip segmentconfigured and dimensioned for engagement with an outer surface of thetissue, the grip segment being adapted to transition between a normalstate, wherein a peripheral portion of the grip segment is orientedtowards the tissue, and an at least partially inverted state, whereinthe peripheral portion of the grip segment is oriented away from thetissue; an expandable section having a proximal end secured to the gripsegment such that the expandable section extends distally from the gripsegment, and a distal end opposite the proximal end, the expandablesection defining a longitudinal axis, and being configured anddimensioned for movement between an initial condition and an expandedcondition; and a dilator element configured and dimensioned forinsertion into the expandable section to cause the expandable section totransition to the second expanded condition during advancement of thedilator element through the expandable section to thereby facilitatesecurement of the expandable section relative to the tissue.
 15. Thesurgical anchoring apparatus according to claim 14 wherein the dilatorelement defines a longitudinal passage configured and dimensioned toreceive a surgical object.
 16. The surgical anchoring apparatusaccording to claim 15 further including a seal secured to the dilatorelement, the seal being configured and dimensioned to receive thesurgical object in substantially sealed relation upon insertion of thesurgical object into the longitudinal passage of the dilator element.17. The surgical anchoring apparatus according to claim 14 wherein theexpandable section includes a plurality of expandable segments.
 18. Thesurgical anchoring apparatus according to claim 17 wherein theexpandable section includes a plurality of internal cam surfacesextending inwardly from an internal surface of the expandable section,the internal cam surfaces being obliquely arranged with respect to thelongitudinal axis, the dilator element being configured and dimensionedto contact the cam surfaces to move the expandable segments radiallyoutwardly relative to the longitudinal axis, and thereby move theexpandable section into the expanded condition.
 19. The surgicalanchoring apparatus according to claim 18 wherein each expandablesegment includes an internal cam surface.
 20. The surgical anchoringapparatus according to claim 17 wherein adjacent expandable segments ofthe expandable section are separated by slots.
 21. The surgicalanchoring apparatus according to claim 20 wherein the slots aresubstantially linear in configuration.
 22. The surgical anchoringapparatus according to claim 14 wherein the expandable section includesan outer helical thread configured and dimensioned to facilitateadvancement of the expandable section through the tissue when theexpandable section is in the initial condition.
 23. The surgicalanchoring apparatus according to claim 14 wherein the grip segment isconfigured and dimensioned for manual engagement by a user.
 24. Thesurgical anchoring apparatus according to claim 14 wherein the gripsegment depends radially outwardly relative to the longitudinal axis.25. The surgical anchoring apparatus according to claim 14 wherein thegrip segment comprises an elastomeric material.
 26. The surgicalanchoring apparatus according to claim 14 wherein the grip segmentincludes a peripheral flange configured and dimensioned to contact thetissue when the grip segment is in the normal state.
 27. The surgicalanchoring apparatus according to claim 26 wherein the peripheral flangeis configured and dimensioned to form a vacuum seal with the tissue asthe grip segment transitions from the at least partially inverted stateto the normal state.
 28. The surgical anchoring apparatus according toclaim 9 wherein the grip segment is positioned in a convex orientationin the normal state, wherein an outer surface of the grip segmentextends towards the tissue such that the grip segment defines across-sectional dimension increasing in a distal direction, and the gripsegment is positioned in a concave orientation in the at least partiallyinverted state, wherein an outer surface of the grip segment extendsaway from the tissue such that the grip segment defines across-sectional dimension decreasing in a distal direction.
 29. Thesurgical anchoring apparatus of claim 14 wherein the grip segment ispositioned in a convex orientation in the normal state, wherein an outersurface of the grip segment extends towards the tissue such that thegrip segment defines a cross-sectional dimension increasing in a distaldirection, and the grip segment is positioned in a concave orientationin the at least partially inverted state, wherein an outer surface ofthe grip segment extends away from the tissue such that the grip segmentdefines a cross-sectional dimension decreasing in a distal direction.